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Flavopiridol in Treating Patients With Recurrent, Locally Advanced, or Metastatic Soft Tissue Sarcoma
This study is ongoing, but not recruiting participants.
First Received: July 5, 2000   Last Updated: July 23, 2008   History of Changes
Sponsor: NCIC Clinical Trials Group
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00005974
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of flavopiridol in treating patients who have recurrent, locally advanced, or metastatic soft tissue sarcoma.


Condition Intervention Phase
Sarcoma
Drug: alvocidib
Phase II

Study Type: Interventional
Study Design: Treatment
Official Title: A Phase II Study of Flavopiridol (HMR 1275; NSC 649890) in Patients With Previously Untreated Metastatic or Locally Advanced Soft Tissue Sarcoma

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: July 2000
Detailed Description:

OBJECTIVES: I. Determine the efficacy of flavopiridol in terms of response rate in patients with previously untreated metastatic or locally advanced soft tissue sarcoma. II. Determine the toxicity of this regimen in these patients. III. Determine the time to progression, early progression rate, and response duration in patients treated with this regimen.

OUTLINE: This is a multicenter study. Patients receive flavopiridol IV over 1 hour daily on days 1-3. Treatment continues every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed at 4 weeks and then every 3 months until disease progression or death.

PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study over 12-18 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Histologically confirmed previously untreated metastatic or locally advanced soft tissue sarcoma not amenable to standard curative therapies Measurable disease At least 20 mm by conventional techniques OR At least 10 mm by spiral CT scan Bone lesions are not considered measurable Must have measurable disease outside irradiated area unless evidence of progression or new lesions inside irradiated area No carcinosarcoma, Kaposi's sarcoma, soft tissue Ewing's sarcoma, or embryonal rhabdomyosarcoma

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: Absolute granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than upper limit of normal (ULN) AST no greater than 2.5 times ULN Renal: Creatinine no greater than ULN Cardiovascular: If history of cardiac disease, cardiac ejection function greater than 50% No clinically significant cardiac symptomatology Pulmonary: If history of symptomatic pulmonary disease, FEV1, FVC, and TLC greater than 60% predicted and DLCO greater than 50% predicted No clinically significant pulmonary symptomatology Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No other concurrent serious disease

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior stem cell transplantation Chemotherapy: No prior chemotherapy for metastatic or locally advanced disease No prior high dose chemotherapy and stem cell transplantation Prior adjuvant chemotherapy allowed At least 6 months since prior chemotherapy No other concurrent cytotoxic chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy and recovered No more than 25% of functioning bone marrow irradiated No concurrent radiotherapy to sole site of measurable disease Surgery: At least 4 weeks since prior major surgery Other: No other concurrent anticancer therapy

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005974

  Hide Study Locations
Locations
United States, Minnesota
St. Mary's/Duluth Clinic Health System
Duluth, Minnesota, United States, 55805
Canada
Lions Gate Hospital
North Vancouver, Canada, V7L 2P9
Canada, Alberta
Lethbridge Cancer Clinic
Lethbridge, Alberta, Canada, T1J 1W5
Tom Baker Cancer Center - Calgary
Calgary, Alberta, Canada, T2N 4N2
Canada, British Columbia
BC Cancer Agency
Vancouver, British Columbia, Canada, V5Z 4E6
British Columbia Cancer Agency - Fraser Valley Cancer Centre
Surrey, British Columbia, Canada, V3V 1Z2
Burnaby Hospital Regional Cancer Centre
Burnaby, British Columbia, Canada, V5H 4C2
Capital Health Region (Endeavor Clinical Research)
Victoria, British Columbia, Canada, V8V 3N1
Nanaimo Cancer Clinic
Nanaimo, British Columbia, Canada, V9S 2B7
Penticton Regional Hospital
Penticton, British Columbia, Canada, V2A 3G6
Prostate Centre at Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z 3J5
St. Paul's Hospital - Vancouver
Vancouver, British Columbia, Canada, V6Z 1Y6
Canada, New Brunswick
Doctor Leon Richard Oncology Centre
Moncton, New Brunswick, Canada, E1C 8X3
Moncton Hospital
Moncton, New Brunswick, Canada, E1C 6ZB
Saint John Regional Hospital
Saint John, New Brunswick, Canada, E2L 4L2
Canada, Newfoundland and Labrador
Dr. H. Bliss Murphy Cancer Centre
St. Johns, Newfoundland and Labrador, Canada, A1B 3V6
Canada, Nova Scotia
Nova Scotia Cancer Centre
Halifax, Nova Scotia, Canada, B3H 1V7
Canada, Ontario
Cancer Care Ontario - Windsor Regional Cancer Centre
Windsor, Ontario, Canada, N8W 2X3
Cancer Care Ontario-London Regional Cancer Centre
London, Ontario, Canada, N6A 4L6
Credit Valley Hospital
Mississauga, Ontario, Canada, L5M 2N1
Hamilton and Disrict Urology Association
Hamilton, Ontario, Canada, L8N 1T8
Hotel Dieu Hospital - St. Catharines
St. Catharines, Ontario, Canada, L2R 5K3
Humber River Regional Hospital
Weston, Ontario, Canada, M9N 1N8
Northeastern Ontario Regional Cancer Centre, Sudbury
Sudbury, Ontario, Canada, P3E 5J1
London Health Sciences Centre
London, Ontario, Canada, N6A 4G5
Male Health Centre/CMX Research Inc.
Oakville, Ontario, Canada, L6H 3PI
Markham Stouffville Hospital
Markham, Ontario, Canada, L3P 7T3
Mount Sinai Hospital - Toronto
Toronto, Ontario, Canada, M5G 1X5
North York General Hospital, Ontario
North York, Ontario, Canada, M2E 1K1
Lakeridge Health Oshawa
Oshawa, Ontario, Canada, L1G 2B9
Northwestern Ontario Regional Cancer Centre, Thunder Bay
Thunder Bay, Ontario, Canada, P7A 7T1
Ottawa Regional Cancer Centre - General Campus
Ottawa, Ontario, Canada, K1H 1C4
Peterborough Oncology Clinic
Peterborough, Ontario, Canada, K9H 7B6
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
St. Michael's Hospital - Toronto
Toronto, Ontario, Canada, M5B 1W8
Saint Joseph's Health Centre - Toronto
Toronto, Ontario, Canada, M6R 1B5
Scarborough Hospital - General Site
Scarborough, Ontario, Canada, M1P 2V5
Royal Victoria Hospital, Barrie
Barrie, Ontario, Canada, L4M 6M2
Toronto East General Hospital
Toronto, Ontario, Canada, M4C 3E7
Toronto General Hospital
Toronto, Ontario, Canada, M5G 2C4
Toronto Sunnybrook Regional Cancer Centre
Toronto, Ontario, Canada, M4N 3M5
Trillium Health Centre
Mississauga, Ontario, Canada, L5B 1B8
William Osler Health Centre
Brampton, Ontario, Canada, L6W 2Z8
Women's College Campus, Sunnybrook and Women's College Health Science Center
Toronto, Ontario, Canada, M5S 1B6
York County Hospital
Newmarket, Ontario, Canada, L3Y 2P9
Canada, Prince Edward Island
Queen Elizabeth Hospital, PEI
Charlottetown, Prince Edward Island, Canada, C1A 8T5
Canada, Quebec
Centre Hospitalier de l'Universite' de Montreal
Montreal, Quebec, Canada, H2W 1T8
Centre Hospitalier Regional de Lanaudiere
Joliette, Quebec, Canada, J6E 6J2
Centre Hospitalier Regional de Rimouski
Rimouski, Quebec, Canada, G5L 5T1
Centre Hospitalier Universitaire de Quebec, Pavillion de Quebec
Quebec City, Quebec, Canada, G1R 2J6
Hopital du Saint-Sacrament, Quebec
Quebec City, Quebec, Canada, G1S 4L8
Hopital Charles Lemoyne
Greenfield Park, Quebec, Canada, J4V 2H1
Hopital Du Sacre-Coeur de Montreal
Montreal, Quebec, Canada, H4J 1C5
Centre Universitaire de Sante de l'Estrie - Site Fleurimont
Fleurimont, Quebec, Canada, J1H 5N4
Hopital Sainte Justine
Montreal, Quebec, Canada, H3T 1C5
Kells Medical Research Group Inc.
Pointe Claire, Quebec, Canada, H9R 4S3
L'Hopital Laval
Ste-Foy, Quebec, Canada, G1V 4G5
Maisonneuve-Rosemont Hospital
Montreal, Quebec, Canada, H1T 2M4
McGill University Department of Oncology
Montreal, Quebec, Canada, H2W 1S6
Canada, Saskatchewan
Allan Blair Cancer Centre
Regina, Saskatchewan, Canada, S4T 7T1
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, Canada, S7N 4H4
Sponsors and Collaborators
NCIC Clinical Trials Group
Investigators
Study Chair: Donald G. Morris, MD, PhD, FRCPC Tom Baker Cancer Centre - Calgary
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000067961, CAN-NCIC-IND136, NCI-NCIC-136
Study First Received: July 5, 2000
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00005974     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage III adult soft tissue sarcoma
stage IV adult soft tissue sarcoma

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions
Neoplasms, Connective and Soft Tissue
Flavopiridol
Neoplasms
Therapeutic Uses
Sarcoma
Growth Inhibitors

ClinicalTrials.gov processed this record on November 30, 2009